Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.

NCT05375097 | Completed

• 1 other identifier: CAMG334AFI03
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for the study.

Conditions

Migraine

Keywords

Erenumab,; CGRP,; real world evidence,; sick leaves,; working impairment,; health care visits,; prescriptions,; migraine

Outcome Measures

Primary Outcomes (1)

• Number of sick leave days (headache)

  Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.

  throughout the study, approximately 2 years

Secondary Outcomes (4)

• Change in number of sick leave days (all cause)

  throughout the study, approximately 2 years

• Change in number of healthcare visits (head-ache related)

  throughout the study, approximately 2 years

• Change in number of healthcare visits (all cause)

  throughout the study, approximately 2 years

• Medication patterns: Number of patients receiving medications of interest

  throughout the study, approximately 2 years

Study Arms (2)

Erenumab responder patients

Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses

Other: Erenumab

Migraine controls

Age and gender matched migraine patients on triptan medication, excluding those on botulinum toxin, erenumab and fremanezumab to benchmark the level of HCRU, sick leaves, and medication patterns

Interventions

Erenumab OTHER

Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses

Erenumab responder patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients on erenumab treatment

You may qualify if:

• Adult patients on erenumab treatment ATC: N02CX07
• Diagnosis of migraine (ICD G43)
• Consented
• Occupational healthcare

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CAMG334AFI03 from the Novartis Clinical Trials Results Database

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: July 3, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

US (1)